Description of Event or Problem · 0
ON FEBRUARY 10, 2026, EVENT MEDICAL RECEIVED AN EMAIL NOTIFICATION FROM ITS DISTRIBUTOR ZEUS MEDICA, LOCATED IN ALGERIA, REPORTING TWO PATIENT DEATHS ALLEGEDLY OCCURRING WHILE PATIENTS WERE RECEIVING THERAPY WITH EVENT MEDICAL EVOLUTION 3E VENTILATORS, MODEL: EVL100000-HP-NF, SERIAL NUMBERS:(B)(6) AND LATER ON FEB 19TH , DISTRIBUTOR CHANGED THE SERIAL NUMBERS TO (B)(6). THE NOTIFICATION WAS RECEIVED SOLELY VIA EMAIL FROM THE DISTRIBUTOR. NO FORMAL COMPLAINT REPORT, SERVICE REPORT, OR OTHER OFFICIAL DOCUMENTATION WAS PROVIDED WITH THE NOTIFICATION. TO DATE, EVENT MEDICAL HAS NOT RECEIVED ANY DIRECT COMMUNICATION FROM THE HOSPITAL WHERE THE EVENTS ALLEGEDLY OCCURRED. UPON RECEIPT OF THE DISTRIBUTOR'S EMAIL, EVENT MEDICAL INITIATED ITS COMPLAINT HANDLING AND INVESTIGATION PROCESS AND REQUESTED DETAILED INFORMATION FROM THE DISTRIBUTOR TO ALLOW EVALUATION OF THE REPORTED EVENTS. FORMAL REQUESTS FOR SUPPORTING DOCUMENTATION AND DEVICE DATA WERE SENT TO THE DISTRIBUTOR ON FEBRUARY 10TH, FEBRUARY 11TH , FEBRUARY 12TH , FEBRUARY 17TH, MEETING WITH DEALER TECHNICIAN ON FEBRUARY 24TH 2026. THE REQUESTED INFORMATION INCLUDED, BUT WAS NOT LIMITED TO: COMPLETED SERVICE FORMS, ADDITIONAL INFORMATION FORMS, COMPLETE VENTILATOR SYSTEM LOGS, ALARM AND EVENT LOGS, CALIBRATION RECORDS, VENTILATOR CONFIGURATION DETAILS, OBJECTIVE MEASUREMENT DATA SUPPORTING THE ALLEGED VOLUME DEVIATION, ANY OFFICIAL DOCUMENTATION FROM THE HOSPITAL. DESPITE MULTIPLE FOLLOW-UP ATTEMPTS, THE DISTRIBUTOR HAS NOT PROVIDED THE REQUESTED DOCUMENTATION OR DATA REQUIRED TO SUPPORT A TECHNICAL INVESTIGATION OF THE DEVICES. ON FEBRUARY 20, 2026, EVENT MEDICAL ISSUED A FORMAL NOTICE OF NON-CONFORMANCE TO ZEUS MEDICA DUE TO THE DISTRIBUTOR'S FAILURE TO PROVIDE THE INFORMATION REQUIRED UNDER: THE QUALITY AGREEMENT AND DISTRIBUTION CONTRACT OBLIGATIONS SO, 13485:2016 - CLAUSE 8.2.2 (COMPLAINT HANDLING) EU MDR 2017/745 - ARTICLES 83-87 (POST-MARKET SURVEILLANCE AND VIGILANCE). FDA 21 CFR 820.198 (COMPLAINT FILES). IN AN ADDITIONAL EFFORT TO OBTAIN INFORMATION DIRECTLY FROM THE CLINICAL SITE, EVENT MEDICAL TRIED TO CONTACT THE HOSPITAL ON MARCH 2, 2026. NO RESPONSE HAS BEEN RECEIVED TO DATE. FURTHER FOLLOW-UP ATTEMPTS WERE MADE WITH THE DISTRIBUTOR ON MARCH 2 AND MARCH 6, 2026; HOWEVER, THE DISTRIBUTOR HAS NOT PROVIDED THE REQUESTED DEVICE INFORMATION, EVENT DETAILS, OR SYSTEM LOGS REQUIRED TO SUPPORT THE INVESTIGATION. DUE TO THE ABSENCE OF OBJECTIVE DEVICE DATA, SUPPORTING DOCUMENTATION, AND FORMAL SERVICE RECORDS, EVENT MEDICAL HAS NOT BEEN ABLE TO COMPLETE A TECHNICAL EVALUATION OR DETERMINE WHETHER THE DEVICE CONTRIBUTED TO THE REPORTED PATIENT OUTCOMES. AT THIS TIME, THE INVESTIGATION REMAINS INCONCLUSIVE DUE TO INSUFFICIENT INFORMATION. FOR THIS REASON WE CANNOT ACHIEVE ANY CONCLUSION FOR THIS SITUATION AND WE WILL CLOSE THIS MATER AS "INSUFFICIENT EVIDENCES PROVIDED".